Jim Wagner Controlled Environment Consulting, LLC

Jim Wagner, the President of Controlled Environment Consulting (CEC), has been involved in the Controlled Environment performance evaluation industry since 1979. His consulting includes design and evaluation of sterile compounding facilities, containment facilities and other engineering controls.  Jim conducts international training on cleanroom and containment device certification. Prior to founding CEC, Jim was the President of Micro-Clean, a certification and validation company.  Jim led the Controlled Environment Testing Association’s (CETA) efforts to develop guidance documents for compliance with USP Chapter 797.  He was a member of the USP Council of Experts for Compounding and an expert panel member for USP <800>.  Jim is a current member of the USP Compounding Expert Committee responsible for revisions to USP <797> and <795>.  Jim is a steering committee member for NSF/ANSI standard 49 Biosafety Cabinetry: Design, Construction, Performance, and Field Certification.  Jim was a two-time president of the Controlled Environment Testing Association including being CETA’s first president in 1991-92.  Jim was awarded CETA’s Mel First award for outstanding contributions to the advancement of certification and testing of controlled environments.